Safety of interferon β-1a for treatment of COVID-19： a real-world study based on FAERS database
10.19428/j.cnki.sjpm.2023.22768
- VernacularTitle:干扰素β-1a治疗新型冠状病毒感染的不良反应事件分析
- Author:
Rongqing YANG
1
;
Yongqing GAO
2
;
Fangyuan HU
3
;
Yinghong ZHAI
2
;
Kuiling WANG
4
;
Chang LU
5
;
Jia HE
2
;
Haiying ZHANG
1
Author Information
1. School of Public Health, Guangxi Medical University, Nanning, Guangxi 530021, China
2. School of Medicine, Tongji University, Shanghai 200092, China
3. Naval Hospital of Eastern Theater, Zhoushan, Zhejiang 316004, China
4. Department of Reception and Follow-up, Tianjin Rehabilitation and Recuperation Center, Joint Logistics Support Force of Chinese People's Liberation Army, Tianjin 300110, China
5. Tianjin Medical University, Tianjin 300070, China
- Publication Type:Journal Article
- Keywords:
interferon β-1a;
coronavirus disease 2019;
information component;
reporting odds ratio;
adverse drug event
- From:
Shanghai Journal of Preventive Medicine
2023;35(6):549-554
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo systematically evaluate the safety of interferon β-1a for treatment of corona virus disease 2019 （COVID-19）， and to provide references for interferon β-1a's clinical application. MethodsThis study was conducted with the database from US Food and Drug Administration adverse event reporting system （FAERS） from January 1， 2015 to March 31， 2021. Information component （IC） and reporting odds ratio （ROR） methods were applied for signal mining. ResultsA total of 463 700 records of COVID-19 were selected for analysis， and 45 positive drug adverse event signals were detected. Headache （IC025=1.09， ROR025=2.28）， pyrexia （IC025=0.51， ROR025=1.51） and multiple sclerosis relapse （IC025=3.67， ROR025=14.71） were positive adverse events with higher frequency. Autoimmune disorder （IC025=4.42， ROR025=24.03）， streptococcal infection （IC025=4.12， ROR025=19.82）， and multiple sclerosis relapse （IC025=3.67， ROR025=14.71） were positive adverse events. Acute lung injury， cardio-respiratory arrest and metabolic acidosis were associated with a higher proportion and frequency of death. ConclusionThere are certain safety issues with interferon β-1a in the treatment of COVID-19， and some adverse events with high frequency and high death rate deserve further attention by medical staffs.
